Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm, exploratory trial to evaluate the efficacy and safety of neoadjuvant WX-0593 in patients with resectable ALK-positive or ROS1- positive non-small cell lung cancer(NSCLC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pingping Song

Criteria

Inclusion Criteria:

• Histologically confirmed non-small cell lung cancer (NSCLC).

• ALK-positive or ROS1-positive NSCLC in Stage IB-IIIA (according to the 8th American Joint Committee on Cancer TNM edition), as assessed by investigator.

• Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialized in oncologic procedures).

• ECOG Performance Status of 0-1.

• At least one measurable lesion according to RECIST 1.1.

• Adequate organ and marrow function.

Exclusion Criteria:

• Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug.

• Prior treatment with ALK TKI or ROS1 TKI.

• Prior treatment with local radiotherapy.

• Mixed small cell and NSCLC histology.

• Patients who are candidates to undergo only segmentectomies or wedge resections.